BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE-STEP SUPRAPUBIC INTRODUCER

    MDR report key: 7374201 · Received March 27, 2018

    Report

    Report Number
    1820334-2018-00819
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Report Date
    July 25, 2018
    Manufacturer
    COOK INC
    Product Code
    KGZ
    UDI-DI
    00827002266667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION OF THE RETURNED UNUSED PRODUCT WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED. THIS INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, AND SPECIFICATIONS. ONE UNOPENED PACKAGE LABELED RPN SANT-22-20-PLV, LABEL LOT NUMBER 7924797 WAS RECEIVED. A TRIANGULAR SHAPED PUNCTURE WAS CONFIRMED IN THE PACKAGE TYVEK MATERIAL. THE PUNCTURE COMPLETELY PENETRATED THE PACKAGING MATERIAL. THE STERILITY HAS BEEN COMPROMISED. THE PACKAGE WAS OPENED TO EXAMINE THE PROTECTIVE COVER ON THE NEEDLE TIP. THE NEEDLE HAS PENETRATED THE PROTECTIVE COVER EXPOSING THE NEEDLE TIP. THEREBY ENABLING THE NEEDLE TO PUNCTURE THROUGH THE TYVEK MATERIAL OF THE PACKAGE. THE DEVICE HISTORY LOT RECORD NOTED THREE NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. ONE NON-CONFORMANCE FOR INCORRECT QUANTITY, ONE FOR WORK ORDER INCORRECT, INCOMPLETE OR MISSING INFORMATION AND 44 PRODUCTS PACKAGED INCORRECTLY. THIS WAS RELATED TO THE POUCH FOR THE PRODUCT RATHER THAN THE PRODUCT PROTECTOR THAT CONTRIBUTED TO THE COMPLAINT. A SEARCH OF COMPLAINT RECORDS FOUND THIS IS THE ONLY COMPLAINT ASSOCIATED WITH LOT NUMBER 7924797. IT WAS NOTED, THE SAME CUSTOMER HAS REPORTED A SIMILAR COMPLAINT FOR THE SAME PART NUMBER BUT FOR A DIFFERENT LOT NUMBER. A DOCUMENT REVIEW IDENTIFIED THAT 100% OF PRODUCT IS INSPECTED AFTER PACKAGING FOR DEFECTS INCLUDING DEFECTS SUCH AS: CUTS, HOLES, HAIR, BURN. IT WAS IDENTIFIED THAT THE PRODUCT WAS INCLUDED IN THE SCOPE OF A SHIPPING VALIDATION. A REVIEW OF THE RETURNED PRODUCT CONFIRMED THE COMPLAINT, A HOLE WAS FOUND IN THE PACKAGING. A PRODUCT PROTECTOR THAT IS PLACED OVER THE NEEDLE AT THE TIP OF DEVICE WAS FOUND TO HAVE BEEN PENETRATED BY THE NEEDLE AND THE PACKAGING WAS IN TURN PUNCTURED RESULTING IN STERILITY BEING COMPROMISED. THE PACKAGE PROTECTION APPEARS TO HAVE FOLDED OVER DURING EITHER SHIPPING OR PRODUCT HANDLING RESULTING IN IT BEEN PENETRATED AND THEN IN TURN THIS RESULTED IN THE PACKAGING BEING PUNCTURED. THE CAUSE OF THIS COMPLAINT IS DURING SHIPPING OR HANDLING OF THE PRODUCT THE NEEDLE PIERCED THE PRODUCT PROTECTOR AND THE PACKAGING. THE CAUSE IS RELATED TO SHIPPING AND HANDLING OF THE PACKAGED PRODUCT. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ONE-STEP SUPRAPUBIC INTRODUCER HAD A PIN HOLE IN ITS UNOPENED ORIGINAL PACKAGING. THIS PACKAGING DEFECT WAS FOUND BY THE SURGERY INVENTORY COORDINATOR BEFORE USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. THIS REPORT IS ASSOCIATED WITH MEDWATCH 1820334-2018-00820. ADDITIONAL INFORMATION RECEIVED STATES THAT THEY USED ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: EXEMPT. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ONE-STEP SUPRAPUBIC INTRODUCER HAD A PIN HOLE IN ITS UNOPENED ORIGINAL PACKAGING. THIS PACKAGING DEFECT WAS FOUND BY THE SURGERY INVENTORY COORDINATOR BEFORE USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. THIS REPORT IS ASSOCIATED WITH MEDWATCH 1820334-2018-00820.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215583 ONE-STEP SUPRAPUBIC INTRODUCER KGZ ACCESSORIES, CATHETER KGZ COOK INC 7924798 00827002266667

    Patients

    Seq Age Sex Outcome Treatment
    1